Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease

NCT04585386 | Terminated

• 1 other identifier: 2020-A01625-34
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.

Conditions

Lumbar Disc Disease

Outcome Measures

Primary Outcomes (1)

• Evolution of the lumbar pain

  The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.

  1 hour after the start of the port

Secondary Outcomes (2)

• To assess the safety and tolerance of the devices

  Between Day 0 and Day 8

• Satisfaction of the patient

  After a period of 8 days of wearing the medical device

Study Arms (2)

ATLAS

EXPERIMENTAL

Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.

Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire

Standard lumbar support belt

ACTIVE COMPARATOR

Standard lumbar support belt : LombaSkin® or Lombogib®

Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire

Interventions

Visual analog scale OTHER

to measure the lumbar and radicular pain felt by the patient.

ATLAS; Standard lumbar support belt

Mac Gill Pain Questionnaire OTHER

self-questionnaire that allows a qualitative assessment of chronic pain

ATLAS; Standard lumbar support belt

Roland and Morris Disability Questionnaire OTHER

functional disability scale for assessing low back pain

ATLAS; Standard lumbar support belt

Quebec questionnaire OTHER

To access the patient's perception of incapacity

ATLAS; Standard lumbar support belt

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from subacute (for 6 to 12 weeks) or chronic (\> 3 months) lumbar pain;
• Lumbar disc disease confirmed by Magnetic Resonance Imaging (MRI) less than 3 months old;
• Patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity;
• Patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations;
• Patient capable of understanding the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), of reading the information leaflet, of completing questionnaires and agreeing to sign the consent form.

You may not qualify if:

• Patient with neurological radicular or medullary deficits;
• Patient presenting a postural problem with lateralized contracture;
• Skin pathology in the trunk region and / or contusions and injuries by stretching the trunk;
• History of spinal arthrodesis surgery;
• History of cauda equina syndrome;
• Patient treated by implanted neurostimulation;
• Scoliosis with Cobb angle\> 30 °;
• History of recent fracture of the dorsolumbar spine (\<3 months);
• History of recent rib fracture (\<3 months);
• History of recent herniated disc surgery (\<3 months);
• Patient with diagnosed fracture osteoporosis;
• Patient with heart or circulatory disease or respiratory failure;
• Patient presenting with a tumor or infectious process of the vertebrae;
• Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
• Patient not beneficiary of a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Le Bois

Lille, 59000, France

Location

MeSH Terms

Conditions

Intervertebral disc disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 14, 2020
• Study Start: August 18, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)